Pain, AcuteNCT03146832
Therapeutic Strategies During Exposure to Pain in an Experimental Design
A study testing Exposure therapy (according to habituation approach) and Exposure therapy (according to inhibitory learning approach) in people with Pain, Acute, run by Philipps University Marburg at 1 site in Germany.
Trial summary
The goal of the present study is to compare different therapeutic strategies (according to habituation model vs. according to the inhibitory learning approach) during exposure to thermal pain in an experimental design. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Exposure therapy (according to habituation approach) and Exposure therapy (according to inhibitory learning approach)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2017to 15 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female gender
- sufficient knowledge of German language
Who cannot join
- chronic and acute pain conditions
- Raynaud's disease
- high blood pressure
- neuropathy, coronary diseases
- diabetes, current alcohol
- drug or pain-medication (last 24hours)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
Marburg, 35037
About this study
Official title: Exposure Works, But How? Testing Different Therapeutic Strategies During Exposure to Pain in an Experimental Design
The goal of the present study is to compare different therapeutic strategies (according to habituation model vs. according to the inhibitory learning approach) during exposure to thermal pain in an experimental design.
Read the detailed description
Exposure therapy is effective for the treatment of individuals with chronic pain and high levels of fear-avoidance. Nevertheless, mechanisms of change for exposure treatment are not sufficiently investigated. According to the habituation model, the activation of a fear structure leads to a habituation of the initial physical response. Therefore, the therapeutic recommendation is to focus on the reduction of fear during exposure sessions. According to the inhibitory learning approach, however, exposure experiences compete with the original US-CS fear association. Therefore, the therapist should maximize the violation of negative expectancies. The present study intends to compare both strategies during the exposure to pain in an experimental design.
- Conditions
- Pain, Acute
- Being tested
- Exposure therapy (according to habituation approach), Exposure therapy (according to inhibitory learning approach)
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure therapy (according to habituation approach)Behavioural
Exposure instruction focuses on fear reduction during exposure sessions
Exposure therapy (according to inhibitory learning approach)Behavioural
Exposure instruction focuses on expectation violation during exposure sessions
| Study group | Role | What they receive |
|---|---|---|
| Habituation | Experimental | The habituation instruction focuses on changes of the initial physical fear-responses during exposure sessions. It is explained that the level of anxiety will gradually decrease, or habituate, each time someone faces a feared situation. Participants are then instructed to observe their own level of fear during the three practice trials with the thermode. Together with the experimenter, participants have to indicate their level of arousal on an 11-point scale (0= neutral, 10 = very high) in-between and after the three practice trials. After the practice trial, participants are instructed to reconsider their own development of physical responses. Participants are encouraged to remember the development of their level of arousal during the test trail with the thermode. Receives: Behavioral: Exposure therapy (according to habituation approach) |
| Expectation Violation | Experimental | The expectation violation instruction focuses on the verification of negative expectancies during exposures sessions. It is explained that exposure exercises help to create own experiences which allow to directly test negative predicted outcomes. Together with the experimenter, participants are then encouraged to formulate concrete concerns in regard to the practice trail with the thermode. Before the practice trails, participants have to indicate the likelihood of their concerns on an 11-point scale (0= not likely, 10 = very likely). After the practice trails, participants are instructed to evaluate their own concerns by some guided questions (e.g. "What did you learn?"). Participants are encouraged to keep their own experience in mind during the test trail with the thermode. Receives: Behavioral: Exposure therapy (according to inhibitory learning approach) |
| Control | No intervention | Participants in the control group are not provided with information about exposure therapy. Instead, participants listen to a newspaper article which reports on the daily work in a botanical garden. Together with the experimenter, participants are then asked to name the most interesting aspect in the article. Before the practice trails, participants have to rate how likely it is that they would further inform themselves about botanical gardens on an 11-point scale (0= not likely, 10 = very likely). After the practice trails, participants are provided with some further questions about the newspaper article (e.g. "Did you find the newspaper article interesting?"). This cognitive exercise does not cover any pain-related topics and, therefore, does not serve as a distraction instruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain tolerance
Determined by the temperature at which the participant stopped the heat stimulus
Measured: 5 minutes prior and 5 minutes after three exposure practice trials
Secondary outcomes (6)
Pain intensity
Measured on an 11-point scale (0 = no pain; 10 = worst imaginable pain)
Measured: 5 minutes prior and 5 minutes after three exposure practice trials
Pain quality
Measured on an 11-points scale (0 = bearable; 10 = unbearable)
Measured: 5 minutes prior and 5 minutes after three exposure practice trials
Pain Catastrophizing Scale (PCS)
Pain catastrophizing thoughts (e.g. "I worry all the time about whether the pain will end.")
Measured: 1-week prior and 10 minutes after three exposure practice trials
Pain Anxiety Symptom Scale (PASS)
Pain-related anxiety (e.g. "I worry when I am in pain.")
Measured: 1-week prior and 10 minutes after three exposure practice trials
Pain Processing (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV)
Cognitive pain coping strategies (e.g. "When I am in pain, I know several possibilities how to handle them.")
Measured: 1-week prior and 10 minutes after three exposure practice trials
Psychophysiological activation
e.g. skin conductance responses, heart rate
Measured: throughout the experiment (5 minutes prior, during and 10 minutes after three exposure practice trails
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Apr 2017
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants are assigned to one of three experimental groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Anna Glombiewski, Philipps University Marburg
- Investigators
- Julia Anna Glombiewski, Phd, Principal investigator, Department of Clinical Psychology and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146832
- Sponsor's protocol ID
- 2016-33v
- Status last verified
- Jul 2017
- First submitted
- 18 Apr 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure Works, But How? Testing Different Therapeutic Strategies During Exposure to Pain in an Experimental Design
- ClinicalTrials.gov ID
- NCT03146832
- Acronym / sponsor ID
- 2016-33v
- Conditions
- Pain, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the present study is to compare different therapeutic strategies (according to habituation model vs. according to the inhibitory learning approach) during exposure to thermal pain in an experimental design.
Detailed description
Exposure therapy is effective for the treatment of individuals with chronic pain and high levels of fear-avoidance. Nevertheless, mechanisms of change for exposure treatment are not sufficiently investigated. According to the habituation model, the activation of a fear structure leads to a habituation of the initial physical response. Therefore, the therapeutic recommendation is to focus on the reduction of fear during exposure sessions. According to the inhibitory learning approach, however, exposure experiences compete with the original US-CS fear association. Therefore, the therapist should maximize the violation of negative expectancies. The present study intends to compare both strategies during the exposure to pain in an experimental design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- participants are assigned to one of three experimental groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Habituation | Experimental | Behavioral: Exposure therapy (according to habituation approach)The habituation instruction focuses on changes of the initial physical fear-responses during exposure sessions. It is explained that the level of anxiety will gradually decrease, or habituate, each time someone faces a feared situation. Participants are then instructed to observe their own level of fear during the three practice trials with the thermode. Together with the experimenter, participants have to indicate their level of arousal on an 11-point scale (0= neutral, 10 = very high) in-between and after the three practice trials. After the practice trial, participants are instructed to reconsider their own development of physical responses. Participants are encouraged to remember the development of their level of arousal during the test trail with the thermode. |
| Expectation Violation | Experimental | Behavioral: Exposure therapy (according to inhibitory learning approach)The expectation violation instruction focuses on the verification of negative expectancies during exposures sessions. It is explained that exposure exercises help to create own experiences which allow to directly test negative predicted outcomes. Together with the experimenter, participants are then encouraged to formulate concrete concerns in regard to the practice trail with the thermode. Before the practice trails, participants have to indicate the likelihood of their concerns on an 11-point scale (0= not likely, 10 = very likely). After the practice trails, participants are instructed to evaluate their own concerns by some guided questions (e.g. "What did you learn?"). Participants are encouraged to keep their own experience in mind during the test trail with the thermode. |
| Control | No intervention | –Participants in the control group are not provided with information about exposure therapy. Instead, participants listen to a newspaper article which reports on the daily work in a botanical garden. Together with the experimenter, participants are then asked to name the most interesting aspect in the article. Before the practice trails, participants have to rate how likely it is that they would further inform themselves about botanical gardens on an 11-point scale (0= not likely, 10 = very likely). After the practice trails, participants are provided with some further questions about the newspaper article (e.g. "Did you find the newspaper article interesting?"). This cognitive exercise does not cover any pain-related topics and, therefore, does not serve as a distraction instruction. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- female gender
- sufficient knowledge of German language
Key exclusion criteria (6 listed)
- chronic and acute pain conditions
- Raynaud's disease
- high blood pressure
- neuropathy, coronary diseases
- diabetes, current alcohol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure therapy (according to habituation approach)Exposure instruction focuses on fear reduction during exposure sessions | Behavioural | Habituation |
| Exposure therapy (according to inhibitory learning approach)Exposure instruction focuses on expectation violation during exposure sessions | Behavioural | Expectation Violation |
Primary outcome
Pain tolerance
Time frame: 5 minutes prior and 5 minutes after three exposure practice trials
Determined by the temperature at which the participant stopped the heat stimulus
6 secondary outcomes
Pain intensity
Time frame: 5 minutes prior and 5 minutes after three exposure practice trials
Pain quality
Time frame: 5 minutes prior and 5 minutes after three exposure practice trials
Pain Catastrophizing Scale (PCS)
Time frame: 1-week prior and 10 minutes after three exposure practice trials
Pain Anxiety Symptom Scale (PASS)
Time frame: 1-week prior and 10 minutes after three exposure practice trials
Pain Processing (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV)
Time frame: 1-week prior and 10 minutes after three exposure practice trials
Psychophysiological activation
Time frame: throughout the experiment (5 minutes prior, during and 10 minutes after three exposure practice trails
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Pain, Acute
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Anna Glombiewski, Phd principal investigator
Department of Clinical Psychology and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure therapy (according to habituation approach) and Exposure therapy (according to inhibitory learning approach) in people with Pain, Acute, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain tolerance (time frame: 5 minutes prior and 5 minutes after three exposure practice trials). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017; AzTrials last refreshed its copy on 7 Nov 2026.